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A Phase I Study of Tetrathiomolybdate (TM) in Combination With Carboplatin and Pemetrexed in Treatment-Naive Advanced Adenocarcinoma of the Lung

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Study of Tetrathiomolybdate (TM) in Combination With Carboplatin and Pemetrexed in Treatment-Naive Advanced Adenocarcinoma of the Lung

Inclusion Criteria:

- >18 years old

- ECOG 0-1

- Newly diagnosed stage IV adenocarcinoma OR recurrent disease after prior surgery
and/or irradiation

- Patients must not have received prior chemotherapy for any stage non small cell lung
cancer (NSCLC)

- Brain metastases allowed provided they have been controlled for ≥ 2 weeks after
completion of treatment and remain asymptomatic while off corticosteroids for at
least 1 day

- No other prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease-free for 5 years

- Patient or primary care taker must be informed of and understand the investigational
nature of this study and must sign and give written IRB-approved informed consent in
accordance with institutional guidelines.

- If patient is of childbearing potential, she or he must agree to practice an
effective method of birth control prior to study entry, for the duration of study
participation, and for 30 days after the last study dose.

- Patient has adequate organ functions: serum bilirubin ≤ 2.0 mg/dL; ALT ≤ 3 x upper
limit of normal (ULN), or ALT ≤ 5 x ULN if the patient has hepatic metastasis; serum
creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of at least 60 mL/min.

- Patient has adequate bone marrow reserve: ANC ≥ 1,500/uL, Platelet count ≥ 100,000
/uL, and Hemoglobin ≥ 9.0 g/dL.

Exclusion Criteria:

- Patient receiving any concurrent chemotherapy

- Patients who received platinum-based chemotherapy for any purpose

- Patients who had gastric bypass surgery

- Patients taking copper supplementation for medical reasons

- Medical and/or psychiatric problems of sufficient severity to limit full compliance
with the study or expose patients to undue risk

- Known anaphylactic or severe hypersensitivity to study drugs or their analogs.

- Patient has failed to recover from any prior surgery within 4 weeks of study entry.

- Patient has clinical evidence of copper deficiency (i.e. ceruloplasmin level was less
than 15 mg/dL or free serum copper level less than 2.2 g/dL).

- Patients with tumors that are EGFR mutation and ALK positive

- Patients who are pregnant or lactating

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

Determine phase II dose and safety of TM in combination with carboplatin and pemetrexed in newly diagnosed advanced adenocarcinoma of lung

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Eric S Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

September 2016

Related Keywords:

  • Adenocarcinoma
  • Advanced Adenocarcinoma
  • Lung
  • Tetrathiomolybdate
  • Carboplatin
  • Pemetrexed
  • Platinum
  • Newly Diagnosed
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms



University of Rochester Rochester, New York  14642